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510(k) Data Aggregation
(131 days)
The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.
Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.
The proposed OptoMonitor II is a new version of the OptoMonitor System that includes software modifications and new labeling to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion perfusion catheter, for diagnosis and treatment within the vasculature. This device and its components are considered accessories to catheter pressure transducers and are intended for use with legally marketed catheters.
The OptoMonitor II is intended to measure pressure using specifically devoted optical pressure sensing devices. The OptoMonitor II comprises two modes of operation:
- FFR mode using an OptoWire (The FFR mode is exactly the same as the predicate device, there are no changes to FFR mode included in this submission.)
- Pressure mode using an Optical Pressure Catheter (The Pressure mode is a new modality and the subject of this submission)
The OptoMonitor II automatically switches to the proper operational mode upon connecting the device. This information is contained within the EEPROM contained in every device that connect to the OptoMonitor II.
Both modes are nearly the same with the following differences:
- The FFR mode includes the calculation and display of Pd/Pa and FFR values.
- The FFR mode includes the equalization of distal pressure against aortic pressure.
- The pressure mode includes atm (atmosphere) as pressure unit.
- The pressure mode does not allow re-zeroing the distal pressure of more than 50 mmHg when in mmHg, and of more than 300mmHg when in atm unit.
- The pressure is not output on the distal output interface when unit ATM (instead of mmHg).
The proposed OptoMonitor-II includes the Optical Unit (OU), the Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components are exactly the same as the cleared device hardware (K142598 cleared on 06/12/2015), software and labeling (to indicate updated software) is updated with this submission.
OptoMonitor-II is compatible with the cleared Occlusion Perfusion Catheter(OPC) devices as described in the FDA submissions K130525, K154554 & K153488. The OPC catheters are legally marketed devices that are not altered by Opsens. All sizes of Occlusion Perfusion Catheters are compatible with the OptoMonitor II device since the catheters are all within the specified pressure range and the connectors are compliant to Optomonitor requirements.
The device is a non-sterile, non-patient contact device.
The provided document is a 510(k) premarket notification for the OptoMonitor II device. The document states that the OptoMonitor II is an updated version of the OptoMonitor system, primarily involving software modifications and new labeling to expand its indications to include intravascular pressure monitoring during interventional procedures, such as with an occlusion perfusion catheter.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against which a study directly proves the device meets. Instead, it compares the technological characteristics and performance specifications of the proposed OptoMonitor II with its predicate device (OptoMonitor K142598) to establish substantial equivalence. The overall "acceptance criterion" is implicitly that the OptoMonitor II performs comparably to the predicate device and does not raise new questions of safety or effectiveness.
Here's a table based on the "Substantial Equivalence Table" provided, highlighting key performance specifications:
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (OptoMonitor II) |
|---|---|---|
| Operating Temperature | 15°C to 30°C | 15°C to 30°C |
| Transport Temperature | -25°C to 60°C | -25°C to 60°C |
| Operating Relative Humidity | 10% to 85% non-condensing | 10% to 85% non-condensing |
| Storage Temperature | Room Temperature | Room Temperature |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg FFR and catheter low pressure range. Distal high pressure range between -1 (-760 mmHg) atm and 20 atm (152000 mmHg) in high pressure mode. |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg). The high pressure range shall have an accuracy of 4% of reading or 1% of the full scale range whichever is greater. |
| Thermal Zero Shift | <0.3 mmHg/deg C | <0.3 mmHg/deg C |
| Zero Drift | <1 mmHg/h | <1 mmHg/h |
| Electrical Isolation | Class 2 (double isolation) | Class 2 (double isolation) |
| User Interface | Touchscreen | Touchscreen |
| Auto-zeroing | Yes | Yes |
| Real Time Curves | Aortic instantaneous pressure, aortic mean pressure, distal instantaneous pressure, distal mean pressure | Aortic instantaneous pressure, aortic mean pressure, distal instantaneous pressure, distal mean pressure |
| Real Time Numerical Values | Mean aortic pressure, mean distal pressure, mean Pd/mean Pa | Mean aortic pressure, mean distal pressure, mean Pd/mean Pa |
| Recording Values | Instantaneous Pa, Pd and Pd/Pa; mean Pa; mean Pd; mean Pd/mean Pa | Instantaneous Pa, Pd and Pd/Pa; mean Pa; mean Pd; mean Pd/mean Pa |
| Display Monitor | LCD | LCD |
| Aortic Input | High Level (100 mmHg/V) | High Level (100 mmHg/V) |
| Distal pressure output | Low level 5uV/mmHg | FFR mode remains unchanged (Thus, low level 5uV/mmHg for FFR mode). The document does not specify details for the new pressure mode output, only that "The pressure is not output on the distal output interface when unit ATM (instead of mmHg)." |
Summary of the study that proves the device meets (or is equivalent to) the acceptance criteria:
The document describes a "Performance Data" section (7.7) which details the evaluation conducted. The core of the study is a comparison to a predicate device (OptoMonitor K142598) and verification/validation testing of the software update.
- Software Verification and Validation (V&V): This was conducted according to FDA guidance for "moderate" level of concern software. This testing confirmed the system's functionality with the additional software modality (Pressure mode). The key finding was that the "Pressure Mode is a new modality and the subject of this submission," and it primarily involves software differences such as the calculation/display of Pd/Pa and FFR values, equalization of distal pressure, pressure units, and re-zeroing limitations. The V&V activities confirmed these functionalities work as intended.
- Electrical safety and electromagnetic compatibility (EMC): Assessed with respect to the software change, and the system was found to comply with IEC 60601-1 and IEC 60601-1-2 standards.
- Risk Management Report: Reviewed to determine necessary updates for the "Pressure Mode" in relation to existing safety measures. The conclusion was that the Pressure Mode does not add any new questions of safety.
- Hardware: The hardware components are "exactly the same as the cleared device hardware (K142598)." Therefore, no new hardware testing was necessary as part of this submission.
- Comparison to Predicate: The document explicitly states: "Performance testing has confirmed equivalence. No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any test sets. The studies appear to be primarily bench-top engineering verification and validation of software functionalities and hardware compliance, rather than studies involving patient data. There is no mention of data provenance (e.g., country of origin) because clinical data was not required for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The submission relies on engineering verification and validation against established technical standards (e.g., IEC 60601-1, IEC 60601-1-2) and the performance of the legally marketed predicate device, rather than expert-established ground truth from clinical cases. The ground truth for functional performance would be derived from the device's design specifications and the predicate's known performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication method (like 2+1 or 3+1 expert review) was described or necessary for this type of engineering and software verification submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a pressure monitor, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a medical measurement instrument. Its "standalone" performance is assessed through its ability to accurately measure pressure according to its specifications, which was covered by the verification and validation tests and comparison to the predicate device. The functionality of the "Pressure mode" as a new modality involves "software modifications" and its direct performance (accuracy, range, drift, etc.) is what was evaluated.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance data (e.g., pressure accuracy, thermal zero shift, zero drift) is based on engineering specifications and measurements against calibrated references and the established performance of the predicate device. For software functionality, the ground truth is the intended behavior defined in the software requirements specification.
8. The sample size for the training set
The document does not mention a training set. This is not an AI/ML device that requires a training set of data. The software modifications are deterministic rather than machine-learning based.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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